DEVICES AND SYSTEMS FOR BIOMARKER DETECTION

1 . A diagnostic testing device, comprising:

a fluid collector to collect a body fluid; and

a housing, to test and retain the body fluid, the housing comprising:

a collection chamber, having an open end, to receive the fluid collector and contain a stabilization reagent to completely or substantially prevent the degradation or inactivation of a diagnostic marker in the body fluid;

at least one membrane test strip, in fluid communication with the collection chamber, to indicate the presence or absence of at least one diagnostic marker; and

an immunoassay-based fingerprint acquisition pad in fluid communication with the collection chamber, the acquisition pad having at least one control zone including a control reagent to identify the body fluid donor, the reagent including a member of a predetermined ligand/receptor binding pair; and

a plurality of reaction zones, each of which includes a reaction reagent to determine the presence of a specific diagnostic marker in the fluid sample, the reaction reagent including a member of a predetermined ligand/receptor binding pair.

2 . The device of claim 1 , wherein the stabilizing agent is useful to completely or substantially prevent degradation or inactivation of a diagnostic marker selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite.

3 . The device of claim 1 , wherein the stabilizing agent is useful to completely or substantially prevent degradation or inactivation of a diagnostic marker indicative of a disease.

4 . The device of claim 3 , wherein the disease state is selected from the group consisting of a cancer, a metabolic disease, a cardiac disease, diabetes, a bacterial infection, a viral infection, a fungal infection, and a parasitic infection.

5 . The device of claim 1 , wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0, acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, benzoic acid, aluminum potassium sulfate dodecahydrate, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof.

6 . The device of claim 1 , wherein the stabilizing agent is capable of inhibiting degradation of the diagnostic marker to an inhibitory degree, wherein the inhibitory degree is selected from the group consisting of at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, and at least about 99%.

7 . The device of claim 1 , wherein the stabilizing agent has a concentration selected from the group consisting of about 200 parts per million (ppm) to about 2000 ppm, about 400 ppm to about 1600 ppm, about 600 ppm to about 1400 ppm, about 800 ppm to about 1200 ppm, and about 400 ppm to about 600 ppm.

8 . The device of claim 1 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the diagnostic marker for an inhibitory period selected from the group consisting of at least one minute, at least about five minutes, at least about ten minutes, at least about fifteen minutes, at least about thirty minutes, at least about one hour, at least about two hours, at least about four hours, and at least about eight hours.

9 . The device of claim 1 , further comprising an interface in communication with processor, wherein the processor is capable of analyzing the results from the diagnostic testing device, and transmitting the analyzed results to a recipient.

10 . A diagnostic testing device, comprising:

a fluid collector to collect a body fluid; and

a housing, to test and retain the body fluid, the housing comprising:

a collection chamber, having an open end, to receive the fluid collector and containing a stabilization reagent to completely or substantially prevent the degradation or inactivation of a diagnostic marker in the body fluid;

at least one membrane test strip in fluid communication with the collection chamber, to indicate the presence or absence of at least one diagnostic marker; and

an immunoassay-based fingerprint acquisition pad in fluid communication with the collection chamber, the acquisition pad having at least one control zone including a control reagent to identify the fluid sample donor, the reagent including a member of a predetermined ligand/receptor binding pair; and

a plurality of reaction zones, each of which includes a reaction reagent to determine the presence of a specific diagnostic marker in the fluid sample, the reaction reagent including a member of a predetermined ligand/receptor binding pair

wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0, acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, benzoic acid, aluminum potassium sulfate dodecahydrate, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof; and

wherein the body fluid is selected from the group consisting of saliva, a mucous secretion, tears, sweat, semen, urine, a vaginal secretion, exhalate, blood, serum, and an anal secretion.

11 . The device of claim 1 , further comprising an interface in communication with processor, wherein the processor is capable of analyzing the results from the diagnostic testing device, and transmitting the analyzed results to a recipient.

12 . The device of claim 10 , wherein the stabilizing agent is capable of inhibiting degradation of the diagnostic marker to an inhibitory degree, wherein the inhibitory degree is selected from the group consisting of at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, and at least about 99%.

13 . The device of claim 10 , wherein the stabilizing agent has a concentration selected from the group consisting of about 200 parts per million (ppm) to about 2000 ppm, about 400 ppm to about 1600 ppm, about 600 ppm to about 1400 ppm, about 800 ppm to about 1200 ppm, and about 400 ppm to about 600 ppm.

14 . The device of claim 10 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the diagnostic marker for an inhibitory period selected from the group consisting of at least one minute, at least about five minutes, at least about ten minutes, at least about fifteen minutes, at least about thirty minutes, at least about one hour, at least about two hours, at least about four hours, and at least about eight hours.